Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Hydrocortisone
Waymade Healthcare Plc
D07AA02
Hydrocortisone
10mg/1gram
Cutaneous ointment
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13040000
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GB 724-9972-APIL HYDROCORTISONE OINTMENT 1% READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Please keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Hydrocortisone Ointment 1% is and what it is used for 2. What you need to know before you use Hydrocortisone Ointment 1% 3. How to use Hydrocortisone Ointment 1% 4. Possible side effects 5. How to store Hydrocortisone Ointment 1% 6. Contents of the pack and other information 1. WHAT HYDROCORTISONE OINTMENT 1% IS AND WHAT IT IS USED FOR The name of your medicine is Hydrocortisone Ointment 1%. Hydrocortisone Ointment 1% contains the active ingredient hydrocortisone which belongs to a group of medicines called corticosteroids or ‘steroids’. Steroids like hydrocortisone are applied to the skin to reduce inflammation. Hydrocortisone Ointment 1% is used to treat all types of eczema and dermatitis and insect bite reactions. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE HYDROCORTISONE OINTMENT 1% DO NOT USE HYDROCORTISONE OINTMENT 1%: • if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6) (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing). • If you have an infection of the skin which has not been treated; • If you have pale or reddened patches of skin – (usually as a result of an allergy; this is a condition known as urticaria); • If you have a facial skin cond read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrocortisone Ointment 1% 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Hydrocortisone EP 1% w/w 3 PHARMACEUTICAL FORM A smooth, white to off-white ointment 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hydrocortisone Ointment is indicated for the treatment of eczema and dermatitis of all types, including atopic eczema, photodermatitis, otitis externa, primary irritant and allergic dermatitis, intertrigo, prurigo nodularis, seborrhoeic dermatitis and insect bite reactions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children: To be applied sparingly to the affected skin two or three times daily after gently cleansing the area. Courses of treatment in children should generally be limited to not more than seven to ten days. 4.3 CONTRAINDICATIONS Hydrocortisone Ointment is contra-indicated in patients with bacterial, viral or fungal infections of the skin. Urticaria, rosacea, ulcers and local infection are also contra- indications. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Prolonged use in infants and children and on the face should be avoided. Hydrocortisone Ointment is for symptomatic relief and is not curative. For this reason, there is a possibility of rebound of symptoms. Hydrocortisone Ointment is not recommended for pruritis. Topical corticosteroids may be hazardous in patients with psoriasis and should therefore be avoided. Long term use in patients with diabetes or tuberculosis is not recommended. I nstruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No known interactions. 4.6 PREGNANCY AND LACTATION There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant a read_full_document